- Official marketing launch of Mente Autism
- Local registration of the Mente Autism device underway in Italy
- First shipment of devices on track for Q4 CY 2016
Perth, Australia & Malta – 11 November 2016 – Developer of quality medical solutions in the neuroscience space, Neurotech International Limited (ASX: NTI), has conducted the official marketing launch of Mente Autism.
New information on the device can be viewed at www.mentetech.com with an accompanying video demonstrating the product at www.mentetech.com/mente-for-autism.
The marketing launch comes after the receipt of CE Marking for Mente Autism as a Class IIa medical device, designed to help children suffering from autism spectrum disorder (ASD).
The European CE Marking process serves an equivalent function to the US Food Drug and Administration (FDA) clearance or approval routes, assessing the safety and efficacy of new devices in the European Union while being recognised almost worldwide.
Local registration for Mente Autism has now commenced in Italy, along with training of the local distributor’s sales teams and medical experts, with additional marketing initiatives occurring in parallel.
Neurotech management expects these efforts to culminate in the first shipment of Mente Autism devices to the Italian distributor within the current quarter.
Rollout of the Mente Autism device will occur on a country-by-country basis subject to local registration requirements, with initial efforts focussed on key European markets. As part of the marketing launch for Mente Autism, Neurotech management will be present at the Medica International Trade Fair in Düsseldorf, Germany, from 14-17 November. The event is considered to be one of the world’s leading trade fairs within the medical industry.
“The company expects to receive local registration of Mente Autism within Italy in the coming weeks, that being the final step before we can deliver the first devices,” Neurotech’s CEO Wolfgang Storf said.
“We have received widespread interest in the product and look forward to witnessing initial sales of the third iteration of the Mente system, as well as realising first revenues from the device.”
Mente Autism is a clinical-quality EEG device that uses neurofeedback technology to help children with ASD. Designed for home use, Mente Autism helps relax the minds of children on the spectrum which in turns helps them to focus better and engage positively with their environment.
“Mente Autism possesses various upgraded features to improve the performance, convenience and comfort of the device,” Neurotech’s Founder and Chief Scientific Officer Dr Adrian Attard Trevisan said.
“The biggest change sees it now come as a self-contained headband, not requiring connectivity to a smartphone or tablet during the therapy session and therefore allowing the child to move around more freely in that time. The buckle has been centred to provide improved pressure distribution and improves Mente Autism’s capability as a full EEG monitoring device, using five high performance and replaceable sensors. “Importantly we have now established a clinical grade retail platform with Mente Autism, which will allow us to more easily adapt the device for the treatment of other neurological disorders such as epilepsy, anxiety, depression and tinnitus.”
AAT Medical, a wholly owned subsidiary of Neurotech, has also successfully passed an annual audit to maintain its ISO 13485 certification, reconfirming its ability to consistently meet both customer and regulatory requirements for the manufacture of its devices. This standard, developed by the International Organization for Standardization, sets out specific requirements and guidelines for a quality management system for medical device companies to ensure quality control in their procedures and products.
For more information about Neurotech and Mente Autism please visit: www.neurotechinternational.com
www.mentetech.com
